Pharmacokinetics (PK) and Tolerability of AVP-786 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AVP-786 Dose 1; Drug: AVP-786 Dose 1/Q Dose 2; Drug: AVP-786 Dose 2; Drug: AVP-786 Dose 1/Q Dose 1; Drug: AVP-786 Dose 2/Q Dose 2; Drug: AVP-923

• Registration Number: NCT01787747
• Lead Sponsor: Avanir Pharmaceuticals

Brief Summary

To assess the single- and multiple-dose pharmacokinetic (PK), safety and tolerability of AVP-786 in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2013-02-06
• Study First Submitted QC: 2013-02-07
• Study First Posted: 2013-02-11
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-24
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

• Healthy adult males
• 18 - 45 years of age
• BMI 18 - 30 kg/m2

Exclusion Criteria

• History or presence of significant disease
• History of substance and/or alcohol abuse within the past 3 years
• Use of tobacco-containing or nicotine-contining products within 6 months
• Use of any prescription of over-the-counter (OTC) medication within 14 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohorts A and C	AVP-923	Single dose (D1) followed by twice daily dosing for 7 days
Cohorts E and F	AVP-923	Single dose (D1) followed by twice daily dosing for 7 days
Cohorts A and C	AVP-786 Dose 1	Single dose (D1) followed by twice daily dosing for 7 days
Cohorts G and I	AVP-786 Dose 1/Q Dose 2	Single dose (D1) followed by twice daily dosing for 7 days
Cohorts G and I	AVP-923	Single dose (D1) followed by twice daily dosing for 7 days
Cohorts B and D	AVP-786 Dose 2	Single dose (D1) followed by twice daily dosing for 7 days
Cohorts E and F	AVP-786 Dose 1/Q Dose 1	Single dose (D1) followed by twice daily dosing for 7 days
Cohorts B and D	AVP-923	Single dose (D1) followed by twice daily dosing for 7 days
Cohorts H and J	AVP-786 Dose 2/Q Dose 2	Single dose (D1) followed by twice daily dosing for 7 days
Cohorts H and J	AVP-923	Single dose (D1) followed by twice daily dosing for 7 days

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of parent and metabolites	8 Days

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability	8 days	Assessments to include Physical Examination (PE), Labs, ECGs, and Adverse Events (AEs)

Trial Locations

Locations (1)

CMAX; 🇦🇺 Adelaide, South Australia, Australia